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Serving leading biopharmaceutical companies globally:

Cipla
Teva
Fuji
Farmers Insurance
Mallinckrodt
Chubb
Cerilliant
Harvard Business School
US Department of Justice
Novartis

Generated: October 22, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 021880

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NDA 021880 describes REVLIMID, which is a drug marketed by Celgene and is included in one NDA. It is available from one supplier. There are twenty-seven patents protecting this drug and three Paragraph IV challenges. Additional details are available on the REVLIMID profile page.

The generic ingredient in REVLIMID is lenalidomide. There are twelve drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the lenalidomide profile page.

Summary for NDA: 021880

Tradename:
1
Applicant:
1
Ingredient:
1
Patents:27
Therapeutic Class:Antineoplastics
Formulation / Manufacturing:see details

Pharmacology for NDA: 021880

Suppliers and Packaging for NDA: 021880

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
REVLIMID
lenalidomide
CAPSULE;ORAL 021880 NDA Celgene Corporation 59572-402 59572-402-00 100 CAPSULE in 1 BOTTLE (59572-402-00)
REVLIMID
lenalidomide
CAPSULE;ORAL 021880 NDA Celgene Corporation 59572-402 59572-402-28 28 CAPSULE in 1 BOTTLE (59572-402-28)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength5MG
Approval Date:Dec 27, 2005TE:RLD:Yes
Regulatory Exclusivity Expiration:Feb 17, 2018
Regulatory Exclusivity Use:EXPANDED INDICATION FOR THE TREATMENT OF PATIENTS WITH MULTIPLE MYELOMA
Regulatory Exclusivity Expiration:Feb 17, 2022
Regulatory Exclusivity Use:ORPHAN DRUG EXCLUSIVITY
Regulatory Exclusivity Expiration:Feb 22, 2024
Regulatory Exclusivity Use:ORPHAN DRUG EXCLUSIVITY

Expired Orange Book Patents for NDA: 021880

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Celgene
REVLIMID
lenalidomide
CAPSULE;ORAL021880-002Dec 27, 2005► Subscribe► Subscribe
Celgene
REVLIMID
lenalidomide
CAPSULE;ORAL021880-001Dec 27, 2005► Subscribe► Subscribe
Celgene
REVLIMID
lenalidomide
CAPSULE;ORAL021880-004Jun 29, 2006► Subscribe► Subscribe
Celgene
REVLIMID
lenalidomide
CAPSULE;ORAL021880-004Jun 29, 2006► Subscribe► Subscribe
Celgene
REVLIMID
lenalidomide
CAPSULE;ORAL021880-005Dec 21, 2011► Subscribe► Subscribe
Celgene
REVLIMID
lenalidomide
CAPSULE;ORAL021880-006Jun 5, 2013► Subscribe► Subscribe
Celgene
REVLIMID
lenalidomide
CAPSULE;ORAL021880-003Jun 29, 2006► Subscribe► Subscribe
Celgene
REVLIMID
lenalidomide
CAPSULE;ORAL021880-003Jun 29, 2006► Subscribe► Subscribe
Celgene
REVLIMID
lenalidomide
CAPSULE;ORAL021880-006Jun 5, 2013► Subscribe► Subscribe
Celgene
REVLIMID
lenalidomide
CAPSULE;ORAL021880-002Dec 27, 2005► Subscribe► Subscribe
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Serving leading biopharmaceutical companies globally:

Citi
Mallinckrodt
Harvard Business School
Merck
Fish and Richardson
US Army
Cipla
Teva
Medtronic
Farmers Insurance

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

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